Modifications to the List of Recognized Standards, Recognition List Number: 014 includes more than fifty changes to the FDA’s roster of accepted standards. In addition to the withdrawal and/or revision of previously accepted standards, the updated list adds twenty-two newly recognized standards. A searchable database of the current list is maintained on the FDA website.

The standards identified in Recognition List Number: 014 evaluate the safety and performance of an array of medical devices, ranging from medical face masks and examination gloves to radiography equipment and cardiovascular implants. Newly recognized standards include the following:

Developed by ANSI member and accredited standard developer the Association for the Advancement of Medical Instrumentation (AAMI), this document has been adopted as an International Standard by the ISO. The standard describes the selection and use of chemical indicators in medical sterilization processes, and provides guidance in the interpretation of results.

This standard defines criteria to evaluate the durability of knee-joint prostheses. An International Standard, the document specifies the applied force, speed, and duration of wear testing, as well as the environmental conditions under which tests should be performed.

Developed by ANSI member and accredited standards developer, ASTM International, this standard specifies methods to test the resistance of medical gloves to permeation by nine commonly used chemotherapy drugs over a period of extended contact.

This standard was developed by AAMI to ensure the safety of infant radiant warmers—the systems used in hospital delivery rooms and neonatal intensive care units worldwide to keep newborns and high-risk infants warm and comfortable. This document has been adopted as an International Standard by the IEC.